← Product Code [DKB](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB) · K031856

# PRECISET TDM I AND PRECISET TDM II CALIBRATORS (K031856)

_Roche Diagnostics Corp. · DKB · Aug 6, 2003 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB/K031856

## Device Facts

- **Applicant:** Roche Diagnostics Corp.
- **Product Code:** [DKB](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB.md)
- **Decision Date:** Aug 6, 2003
- **Decision:** SESE
- **Submission Type:** Abbreviated
- **Regulation:** 21 CFR 862.3200
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Indications for Use

The Roche Preciset TDM I calibrators are designed for the calibration of the Roche assay for the quantitative determination of digoxin, carbamazepine, gentamicin, phenytoin, phenobarbital, primidone, theophylline, tobramycin, valproic acid, and vancomycin in human serum and plasma on automated clinical chemistry analyzers. The Roche Preciset TDM II calibrators are designed for the calibration of the Roche assay for the quantitative determination of digitoxin, amikacin, lidocaine, N-acetylprocainamide, procainamide, and quinidine in human serum and plasma on automated clinical chemistry analyzers.

## Device Story

Preciset TDM I and II are multi-analyte calibrator sets used to calibrate Roche therapeutic drug monitoring (TDM) assays on automated clinical chemistry analyzers. Each set consists of six levels (A-F) of human serum spiked with specific drug concentrations, plus a drug-free diluent. Bottle A is negative; bottles B-F contain increasing concentrations of the target analytes. Stabilizers and preservatives are added. These calibrators are used by laboratory technicians in clinical settings to establish a calibration curve for quantitative drug measurement. By providing multiple analytes in a single set, the device improves laboratory workflow efficiency compared to using individual single-analyte calibrators. The output is a calibration curve used by the analyzer to calculate patient drug levels, aiding clinicians in therapeutic drug monitoring and dosage adjustment.

## Clinical Evidence

No clinical data. Bench testing only. Traceability established to single analyte primary master calibrators prepared gravimetrically and by dilution from pure drugs of the highest metrological order.

## Technological Characteristics

Multi-analyte calibrator sets consisting of human serum base, stabilizers, and preservatives. Six-level concentration gradient (0 to high-range) for each drug. Designed for use on automated clinical chemistry analyzers. No electronic or software components; purely chemical/biological reagent calibrators.

## Regulatory Identification

A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

## Predicate Devices

- Roche COBAS-FP Reagents and Calibrators for Digoxin ([K851032](/device/K851032.md))
- Roche COBAS-FP Reagents and Calibrators for Carbamazepine ([K850807](/device/K850807.md))
- Roche COBAS-FP Reagents and Calibrators for Gentamicin ([K843827](/device/K843827.md), [K945523](/device/K945523.md))
- Roche COBAS-FP Reagents and Calibrators for Phenytoin ([K936131](/device/K936131.md))
- Roche COBAS-FP Reagents and Calibrators for Phenobarbital ([K936130](/device/K936130.md))
- Roche COBAS-FP Reagents and Calibrators for Primidone ([K852318](/device/K852318.md))
- Roche COBAS-FP Reagents and Calibrators for Theophylline ([K871484](/device/K871484.md))
- Roche COBAS-FP Reagents and Calibrators for Tobramycin ([K843828](/device/K843828.md))
- Roche COBAS-FP Reagents and Calibrators for Valproic Acid ([K925003](/device/K925003.md))
- Roche COBAS-FP Reagents and Calibrators for Vancomycin ([K901759](/device/K901759.md))
- COBAS INTEGRA, Calibrators & Controls ([K972250](/device/K972250.md))
- Roche COBAS-FP Reagents and Calibrators for Amikacin (852317)
- Roche COBAS-FP Reagents and Calibrators for Lidocaine ([K853010](/device/K853010.md))
- Roche COBAS-FP Reagents and Calibrators for NAPA ([K871680](/device/K871680.md))
- Roche COBAS-FP Reagents and Calibrators for Procainamide ([K852320](/device/K852320.md), [K942847](/device/K942847.md)/S2)
- Roche COBAS-FP Reagents and Calibrators for Quinidine ([K941440](/device/K941440.md))

## Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE TEMPLATE

A. 510(k) Number: K031856
B. Analyte: Preciset TDM I and TDM II Calibrators
C. Type of Test: N/A
D. Applicant: Roche Diagnostics
E. Proprietary and Established Names: Preciset TDM I and TDM II Calibrators

F. Regulatory Information:
1. Regulation section: 21 CFR 862.3200
2. Classification: Class II
3. Product Code: DKB
4. Panel: 91

G. Intended Use:
1. Indication(s) for use: The Roche Preciset TDM I calibrators are designed for the calibration of the Roche assay for the quantitative determination of digoxin, carbamazepine, gentamicin, phenytoin, phenobarbital, primidone, theophylline, tobramycin, valproic acid, and vancomycin in human serum and plasma on automated clinical chemistry analyzers.
2. The Roche Preciset TDM II calibrators are designed for the calibration of the Roche assay for the quantitative determination of digitoxin, amikacin, lidocaine, N-acetylprocainamide, procainamide, and quinidine in human serum and plasma on automated clinical chemistry analyzers.
3. Special condition for use statement(s): none
4. Special instrument Requirements: none

H. Device Description: The Roche Preciset TDM I calibrators are designed for the calibration of the Roche assay for the quantitative determination of digoxin, carbamazepine, gentamicin, phenytoin, Phenobarbital, primidone, Theophylline, tobramycin, valproic acid, and vancomycin in human serum and plasma on automated

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clinical chemistry analyzers. The Roche Preciset TDM II calibrators are designed for the calibration of the Roche assay for the quantitative determination of digoxin, amikacin, lidocaine, N-acetylprocainamide, procainamide, and quinidine in human serum and plasma on automated clinical chemistry analyzers. These calibrators are liquid ready to use calibrators consisting of six levels, and a drug free diluent.

## I. Substantial Equivalence Information:

Predicate device name(s): TDM I -Roche COBAS-FP Reagents and Calibrators for Digoxin - K851032, Carbamazepine - K850807, Gentamicin - K843827 & K945523, Phenytoin - K936131, Phenobarbital - K936130, Primidone - K852318, Theophylline - K871484, Tobramycin - K843828, Valproic Acid - K925003, and Vancomycin - K901759 TDM II COBAS INTEGRA, Calibrators & Controls - K972250, Roche COBAS-FP Reagents and Calibrators for Amikacin - 852317, Lidocaine - K853010, NAPA - K871680, Procainamide - K852320 & K942847/S2 and Quinidine - K941440

Predicate K number(s): TDM I -Roche COBAS-FP Reagents and Calibrators for Digoxin - K851032, Carbamazepine - K850807, Gentamicin - K843827 & K945523, Phenytoin - K936131, Phenobarbital - K936130, Primidone - K852318, Theophylline - K871484, Tobramycin - K843828, Valproic Acid - K925003, and Vancomycin - K901759 TDM II COBAS INTEGRA, Calibrators & Controls - K972250, Roche COBAS-FP Reagents and Calibrators for Amikacin - 852317, Lidocaine - K853010, NAPA - K871680, Procainamide - K852320 & K942847/S2 and Quinidine - K941440

## 3. Comparison with predicate:

|  DEVICE | PREDICATE  |
| --- | --- |
|  A. Similarities  |   |
|  Liquid ready to use calibrators, 6 levels, bottles A-F | Liquid ready to use calibrators, 6 levels, bottles A-F  |
|  Human Serum with stabilizer and preservative. | Human Serum with stabilizer and preservative.  |
|  B. Differences  |   |
|  The Roche Preciset TDM I calibrators are designed for the calibration of the Roche assay for the quantitative determination of digoxin, carbamazepine, gentamicin, phenytoin, Phenobarbital, primidone, Theophylline, tobramycin, valproic acid, and vancomycin in human serum and plasma on automated clinical chemistry analyzers. | The predicates (listed in Section H) consisted of individual calibrators for each test.  |
|  The Roche Preciset TDM II calibrators are designed for the |   |

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|  calibration of the Roche assay for the quantitative determination of digoxin, amikacin, lidocaine, N-acetylprocainamide, procainamide, and quinidine in human serum and plasma on automated clinical chemistry analyzers. |   |
| --- | --- |

J. Standard/Guidance Document Referenced (if applicable) Guidance for Industry - Abbreviated 510(k) Submissions for InVitro Calibrators

K. Test Principle: N/A

L. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility: N/A
b. Linearity/assay reportable range: N/A
c. Traceability (controls, calibrators, or method): traceable to single analyte primary master calibrators prepared gravimetrically and by dilution from pure drugs of the highest metrological order
d. Detection limit (functional sensitivity): N/A
e. Analytical specificity: N/A
f. Assay cut-off: N/A

2. Comparison studies:
a. Method comparison with predicate device: N/A
b. Matrix comparison: N/A

3. Clinical studies:
a. Clinical sensitivity: N/A
b. Clinical specificity: N/A

4. Clinical cut-off: N/A

5. Expected values/Reference range: N/A

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**M. Conclusion:**

Based upon the information provided, I recommend that the Roche Preciset TDM I and II multianalyte calibrators be found substantially equivalent with similar defined products based upon 21 CFR 862.3200.

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB/K031856](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB/K031856)

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